Drugs affecting bone structure and mineralisation

Drug Safety Update 

May 2022: Denosumab 60mg (Prolia): should not be used in patients under 18 years due to the risk of serious hypercalcaemia

August 2020: Denosumab 60mg (Prolia): increased risk of multiple vertebral fractures after stopping or delaying ongoing treatment

 June 2018: Denosumab (Xgeva) for giant cell tumour of the bone: risk of clinically significant hypocalcaemia following discontinuation

 June 2018: Denosumab (Xgeva) for advanced malignancies involving bone: study data show new primary malignancies reported more frequently than zoledronic acid

 June 2017: Denosumab: reports of osteonecrosis of the external auditory canal

 July 2015: Denosumab; intravenous bisphosphonates osteonecrosis of the jaw further measures to minimise risk 

 September 2014: Denosumab updated recommendations minimising the risk of osteonecrosis of the jaw and monitoring for hypocalcaemia

 February 2013: Denosumab 60 mg (Prolia▼): Rare cases of atypical femoral fracture with long-term use.

NICE Guidance (see drug-specific links below)

Denosumab: Please click here for the shared care protocol for prescribing denosumab for the treatment of osteoporosis

Please note there various Biosimilars available for both strengths of Denosumab; please ensure the correct brand is selected for the correct indication.

Ensure the selected Brand is continued in primary care.  

Denosumab 60mg for osteoporosis may be prescribed in primary care under a shared care arrangement

KMICB - Denosumab (shared care guidance)

Denosumab 120mg, used in malignancy-related indications, is hospital-only.

Pack
1 pre-filled disposable injection
Pack
1 vial
Pack
1 pre-filled disposable injection
Pack
1 pre-filled disposable injection
  • On Formulary Preferred
  • On Formulary Second Line
  • On Formulary Third Line
  • Specialist Initiation
  • Secondary Care Only
  • Not Approved for Formulary